Evaluation of the Local Effect of Nonsurgical Periodontal Treatment of Generalized Aggressive Periodontitis Associated or Not With Systemic Antibiotics and Photodynamic Therapy.: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Clinical attachment level
研究概览
简要总结
To assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).
详细描述
The aim of the present study was to evaluate the local effect of the antimicrobial therapy using clarithromycin (CLM) association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP). Sixty periodontal pockets were select and randomly assigned into four groups: Periodontal Debridement (PD) (n=15): periodontal pockets that received periodontal debridement (PD) with placebo; PD+CLM (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin; PD+PDT (n=15): periodontal pockets that received periodontal debridement associated with photodynamic therapy; PD+CLM+PDT (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin and photodynamic therapy. Probing depth (PD),gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of GagP
- •presence of ≥20 teeth
- •<35 years of age
- •periodontal pockets with probing depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm with concomitant bleeding on probing (BOP) in single-rooted teeth from different quadrants - agree to participate in the study and sign a written consent.
排除标准
- •pregnant or lactating
- •suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
- •received antimicrobials in the previous 6 months
- •taking long-term anti-inflammatory drugs
- •received a course of periodontal treatment within the last 12 months
研究组 & 干预措施
Periodontal debridement + PDT
Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days) and a single application of PDT (Photodynamic Therapy).
干预措施: periodontal debridement (Procedure)
Periodontal debridement
Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
干预措施: periodontal debridement (Procedure)
Periodontal debridement + CLM
Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours) for 3 days.
干预措施: periodontal debridement (Procedure)
Periodontal debridement + CLM
Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours) for 3 days.
干预措施: systemic clarithromycin (Drug)
Periodontal debridement + PDT
Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days) and a single application of PDT (Photodynamic Therapy).
干预措施: photodynamic therapy (Procedure)
Periodontal debridement + CLM + PDT
Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT.
干预措施: periodontal debridement (Procedure)
Periodontal debridement + CLM + PDT
Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT.
干预措施: photodynamic therapy (Procedure)
Periodontal debridement + CLM + PDT
Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT.
干预措施: systemic clarithromycin (Drug)
结局指标
主要结局
Clinical attachment level
时间窗: 6 months
distance from bottom of pocket to the cement-enamel junction
次要结局
- Probing depth(6 months)
研究者
Mauro Pedrine Santamaria
PhD, Adjunct professor
Universidade Estadual Paulista Júlio de Mesquita Filho